Is Your QMS Haunted? Five Ghosts That Make Quality Hard to Use A walk through the procedures that scare your people more than any FDA investigator. Every October, the neighborhood fills up with inflatable ghosts,...
Read MoreIn medical devices and pharmaceuticals, we talk a lot about quality systems, CAPAs, and regulatory compliance. But after thirty-five years in this industry, from the clinical lab to the boardroom, I’ve realized that the most...
Read MoreAs of February 2, 2026, the medical device industry officially entered a new regulatory era. The long-anticipated transition is complete: the Quality Management System Regulation (QMSR) has modernized 21 CFR Part 820 by integrating ISO...
Read MoreThe FDA’s new Quality Management System Regulation (QMSR) takes effect February 2, 2026, harmonizing with ISO 13485. This shifts the framework from the old, prescriptive QSR to a more proactive, process-based system rooted in risk-management....
Read MoreIn pharmaceuticals and medical devices, “quality” is more than a department, it’s the core of the industry. It’s the difference between a life-saving drug and a catastrophic recall, between a trusted medical implant and a...
Read MoreIt’s World Quality Month, and for those of us in Quality, it’s an interesting annual event. Our work, if we’re doing it well, is meant to be invisible. When we do our jobs perfectly, nothing...
Read More
